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| Name | Class |
|---|---|
| Vivactis M2Research | INDUSTRY |
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Virtual reality has been shown to reduce the pain experienced during medical procedures.
The aim of this study is to determine to what extent the use of this technique could make it possible to defer the administration of neuroleptanalgesia during the endovenous thermal treatment of superficial varicose veins in addition to local anaesthesia by tumescence.
The main objective of the study is to test the non-inferiority of the effect of sedation by the virtual reality device on the intensity of maximum intraoperative pain compared with the usual neuroleptanalgesic treatment, tolerating a margin of non-inferiority of 0.5 points.Pain will be assessed on an ENS immediately at the end of the surgical procedure.
Prospective, randomised, open-label, single-centre study in two parallel groups of 200 patients.
Maximum duration of patient participation in the study = 2 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| usual neuroleptanalgesic treatment | Active Comparator | - Group 1: local anaesthesia by tumescence + neuroleptanalgesia |
|
| use of a device incorporating virtual reality software | Experimental | - Group 2: local anaesthesia by tumescence with virtual reality software |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| use of a device incorporating virtual reality software | Device | use of a device incorporating virtual reality software |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain intensity assessed by NRS (numerical rating scale) | The intensity of maximum pain during the surgery will be assessed by numerical rating scale (NRS) graduated from 0 (no pain) to 10 (worst pain imaginable). | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Level of pre-operative anxiety assessed by the patient using the STAI-Y | The anxiety experienced will be assessed by the patient using the STAI-Y scale (Spielberg State Anxiety Inventory). | Day 0 |
| Level of post-operative anxiety assessed by the patient using the STAI-Y |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lauranne MATRAY, MD | Contact | 05 61 37 81 81 | 33 | dr.lmatray.union@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Lauranne MATRAY, MD | Clinique de l'Union | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique de l'Union | Recruiting | Saint-Jean | 31240 | France |
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| ID | Term |
|---|---|
| D009458 | Neuroleptanalgesia |
| ID | Term |
|---|---|
| D000698 | Analgesia |
| D000760 | Anesthesia and Analgesia |
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Prospective, randomised, open-label, single-centre study in two parallel groups of 200 patients.
Maximum duration of patient participation in the study = 2 days.
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| Neuroleptanalgesia | Drug | Usual neuroleptanalgesic treatment |
|
The anxiety experienced will be assessed by the patient using the STAI-Y scale (Spielberg State Anxiety Inventory). |
| Day 1 |
| treatment administered during the procedure | Nature and quantities of additional sedative treatment administered during the procedure | Day 1 |
| Pain intensity assessed by NRS (numerical rating scale) | Pain intensity assessed by NRS (numerical rating scale) | Day 1 |
| Overall patient satisfaction post-opérative assessed by NRS (numerical rating scale) | Overall patient satisfaction will be assessed by NRS (numerical rating scale) graduated from 0 (not at all satisfied) to 10 (completely satisfied). | Day 0 |
| Overall patient satisfaction day 1 assessed by NRS (numerical rating scale) | Overall patient satisfaction will be assessed by NRS (numerical rating scale) graduated from 0 (not at all satisfied) to 10 (completely satisfied). | Day 1 |
| Surgery duration | Assessment of the surgery duration | Day 0 |
| Length of stay in the ICU | Length of stay in the ICU | Day 1 |
| Length of stay in the hospital | Length of stay in the hospital | Day 1 |
| Resumption of current activities | Resumption of current activities measured by: YES or NO | Day 1 |
| Hôpital Privé de Villeneuve d'Ascq - Ramsay Santé 20 Av. de la Reconnaissance, 59650 Villeneuve-d'Ascq | Recruiting | Villeneuve-d'Ascq | 59650 | France |
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